An experienced engineering professional, who works well in a cross-functional team environment, including leading remote teams. The individual will lead global initiatives to improve customer satisfaction, develop metrics, analyze in depth quality data and others. This will include the development and implementation of information systems and reporting processes to ensure appropriate prioritization of issues based upon risk to the customer and business; leading to resolution through CAPA, recall, or field actions.
Must be able to work independently and resolve product quality issues, regulatory compliance and quality program related issues in a creative, high quality, timely and cost-effective manner. Core values must include commitment to customer excellence with demonstrated ethics and integrity.
Duties and Responsibilities:
Independently communicates within the project teams as well as with Sr. Leadership through project reviews, status reports and metrics. Generation of divisional metrics on a weekly/monthly/quarterly basis.
Perform/supervise investigations into product incident reports of internal (R&D, receiving, production, shipping) & external (customer complaints, service reports) adverse events, with emphasis on use of root cause and/or other analysis tools and verify effectiveness of implemented corrective actions to prevent recurrence of adverse events. Also, review internal and rework notifications/work orders to determine opportunities for corrective action. Key responsibility includes analysis of Out of Box failures/Complaints, generating reports, scoring risk and facilitating quality improvement projects.
Utilizes project management methodology and tools, as well as facilitates meaningful and constructive exchange of ideas and knowledge. Solid understanding on how to effectively drive change in processes with remote teams.
Perform/supervise internal & external audits of applicable QSR/ISO processes and maintenance of applicable QSR databases to meet regulatory information tracking needs. Support Quality Team by addressing Audit Findings, Implementing CAPA, and updating Quality System documentation as needed.
Recommends process improvements and actively stays involved in the global development of processes and tools.
Supporting and contributing to Continuous Improvement and LEAN projects.
Provides project direction and leadership in general quality program issues to support Quality Department effectiveness, in support of quality initiatives, and coordinate internal resources to ensure projects are complete and implemented on time. Recommend and implement enhancements to the Quality System that result in improved business performance, increased customer satisfaction, and simplification of processes.
Other duties as assigned.
BS (MS a plus) in Engineering and/or technical discipline, or equivalent, with minimum of five to eight years related experience and/or training.
Experience with scientific instrumentation in a design and manufacturing environment; in either a quality, regulatory, design, or manufacturing role; within a medical device related company; or equivalent in a complex product environment
Lead Quality auditor, regulatory investigator, or equivalent status, and/or also with having performed internal process audits.
Problem root cause analysis subject expert, hands-on experience individually as well as leading teams.
Verification & validation of changes in medical device environment.
Organizational, time and project management skills.
Knowledge, Skills & Abilities:
Expert level skills for MS Excel and MS PowerPoint. MS Access, Minitab, SAP business information systems a plus.
Expert data analysis skills, including statistical charting, reliability analysis and others.
Working knowledge of Medical Device Regulations and Standards (FDA, ISO 13485, ISO 14971, MDD, IVDD).
Working knowledge of Risk Management ISO14971
Ability to lead teams in process mapping events and solid knowledge of other QE/Six Sigma/Lean tools.
Energetic, results-driven with excellent organizational and prioritization skills.
Excellent written and verbal communication skills and highly effective time management skills.